Table 7.
Commonly reported adverse events (Safety patient population)
| AE description | Tight control N (%) | Standard care N (%) | Total N (%) |
|---|---|---|---|
| Abdominal / GI upset, n (%) | 35 (5·6) | 13 (5·3) | 48 (5·5) |
| Number of patients, n (%) | 31 (30·7%) | 12 (11·4%) | 43 (20·9%) |
| Fatigue (Asthenia, lethargy, malaise), n (%) | 33 (5·3) | 8 (3·3) | 41 (4·7) |
| Number of patients, n (%) | 22 (21·8%) | 8 (7·6%) | 30 (14·6%) |
| Headache / Migraine, n (%) | 27 (4·4) | 11 (4·5) | 38 (4.4) |
| Number of patients, n (%) | 20 (19·8%) | 7 (6·7%) | 27 (13·1%) |
| Infection (Common cold), n (%) | 46 (7·4) | 14 (5·7) | 60 (6·9) |
| Number of patients, n (%) | 34 (33·7%) | 13 (12·4%) | 47 (22·8%) |
| Liver enzyme abnormalities, n (%) | 37 (6·0) | 39 (15·9) | 76 (8·8) |
| Number of patients, n (%) | 23 (22·8%) | 28 (26·7%) | 51 (24·8%) |
| Musculoskeletal pain, n (%) | 28 (4·5) | 8 (3·3) | 36 (4·2) |
| Number of patients, n (%) | 22 (21·8%) | 6 (5·7%) | 28 (13·6%) |
| Nausea, n (%) | 54 (8·7) | 38 (15·4) | 92 (10·6) |
| Number of patients, n (%) | 36 (35·6%) | 27 (25·7%) | 63 (30·6%) |
Number and % of events is out of 620 events in the TC arm and 246 events in the StdC arm.
Number and % of patients is out of 101 patients in the TC arm and 105 patients in the StdC arm.